When a supplement brand or ingredient maker decides to run a clinical study, one of the first choices is who will run it. Many teams start by calling a traditional CRO, a contract research organization that runs studies through physical research sites. Reputable takes a different approach: decentralized, wearable-based studies with IRB oversight, run with participants at home.
Neither model is right for every study. This page compares the two honestly for marketing, R&D, and regulatory teams: how each one works, where each fits, a side-by-side table, and the real limitations of the decentralized model.
A CRO is a company a sponsor hires to plan and run some or all of a clinical study. In the traditional model, the study runs through one or more research sites, such as clinics, hospitals, or dedicated research units. Site investigators and their staff consent participants, run assessments, collect samples, and record data, while the CRO coordinates the sites, monitors their records, manages the data, and reports the results.
Traditional CROs grew up around drug, biologic, and medical device development, and many run large programs across several countries. Some also run supplement and food studies at their sites. Their strength is control: every participant is measured in the same place, with the same equipment, by trained staff.
Reputable runs decentralized clinical trials: participants take part from home and use the product in their daily lives while data is collected. Screening starts from an existing community of health-engaged people who chose to take part in research, and participants bring wearable history that can inform screening and baseline planning. Daily check-ins, automated reminders, and the Heartbeats rewards program keep adherence visible for the whole study.
Studies can combine continuous wearables, at-home labs with blood biomarkers processed through CLIA-certified labs, and established surveys, joined per participant into a single dataset. One team handles the work from protocol to report, and you get progress and outcome updates at pivotal endpoints. There are two ways to run it: a pilot study that looks for signal on a smaller scope, or a full clinical study with a custom protocol, IRB approval, and pre-registered statistical methodology. Full clinical studies support multi-arm and parallel designs. Some teams run one, and some run both.
The traditional column describes how site-based CROs commonly work; individual CROs differ. The Reputable column comes from how Reputable describes its own studies.
| Factor | Traditional site-based CRO | Reputable (decentralized, wearable-based) |
|---|---|---|
| Where participation happens | At one or more research sites. Participants travel to the clinic for scheduled visits. | Remote protocol. Participants use the product in their daily lives while data is collected. |
| Where participants come from | Recruited for each study, typically through sites, patient databases, referrals, and advertising. | Screened and enrolled from an existing participant community, with wearable baselines already on file. |
| Main measurements | In-clinic assessments, site blood draws, imaging, and supervised tests, plus diaries or apps if the protocol adds them. | Continuous wearables (including Oura, Apple Watch, and Whoop), established surveys such as PROMIS and PSQI, and at-home labs with blood biomarkers processed through CLIA-certified labs, joined per participant into a single dataset. |
| Data between visits | Mostly snapshots taken at each visit. | Wearable, lab, and survey data collected on protocol cadence, with adherence visible in real time. |
| Oversight | IRB or ethics committee review, with monitors checking site records under Good Clinical Practice. | IRB oversight built in. ClinicalTrials.gov registration available (not required). |
| Who does the work | Set by the contract, from a single service, such as data management, to full service. | One team handles protocol design, IRB submission, enrollment, data capture, analysis, and reporting. |
| Study formats | From early-phase studies to large trials, often across many sites and countries. | Pilot studies that look for signal on a smaller scope, and full clinical studies that typically run 1 to 6 months, with multi-arm and parallel designs supported. |
| Analysis | Statistical analysis following a prespecified plan. | Pre-registered statistical methodology with formal analysis and p-value reporting. Analysis is statistician-reviewed. |
| Deliverables | Usually a clinical study report and datasets, plus regulatory documents when the program needs them. | Defined by the agreed scope: clinical study report, communications package with claim language guidance, and an anonymized dataset with a codebook. Publication support is an optional add-on, and acceptance is never guaranteed. |
| Budget | Often built from per-site and per-participant costs, monitoring visits, and pass-through costs. | Every study is scoped to your goals, timeline, and budget. There is no one-size protocol and no one-size price. |
A site-based CRO is usually the stronger choice when:
A decentralized, wearable-based study is often a practical fit for supplement and ingredient brands when:
A remote study trades some control for reach and real-world data. Plan for these limits from the start:
Imaging, supervised testing, and close clinical observation cannot happen at home. If your claim depends on one of them, a remote design is the wrong tool.
Devices differ in how they estimate measures like sleep stages or heart rate variability, and composite scores are often proprietary. The protocol should name the exact metric, keep devices consistent where possible, and set a minimum wear time.
Unsupervised measurements vary more than clinic measurements, and missed nights, syncing gaps, or skipped surveys create missing data. The analysis plan has to say how those gaps are handled.
As with any clinical study, who enrolls shapes what the results mean. Clear eligibility criteria and careful screening help a decentralized study enroll participants who reflect your target customer.
Without routine clinic visits, possible adverse events usually come from participant reports. The protocol needs a clear plan for how they are collected, assessed, and escalated.
Participants need a phone, a compatible device, and comfort with apps. That can leave out some people your product serves, unless the study plans for it.
For a broader look at the tradeoffs, see centralized vs decentralized clinical trials.
Start from the evidence you need, not the vendor. A randomized controlled trial (RCT) can be run either way; what changes is where and how outcomes are measured. Write down the claim or decision the study should inform, the primary outcome, and whether that outcome can be measured reliably outside a clinic. If it can, a decentralized study is worth pricing. If it cannot, or your program needs site-based regulatory work, start with a traditional CRO. Either way, ask each partner how they would design your study, which results it could and could not support, and what you will receive at the end.
Brand and ingredient teams: talk with us about your product, the outcome you need to measure, and whether a pilot or a full clinical study is the right size for it.
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